Literature Review: Risk management strategies in post marketing surveillance for drugs

Abstract

Post-marketing surveillance (PMS) plays a critical role in ensuring the safety and efficacy of drugs following marketing authorization. This review explores best practices and advancements in risk management strategies within the European context, focusing on key aspects such as optimizing risk communication, strengthening public engagement, and enhancing cross-border collaboration. Challenges such as data quality, ethical concerns, and balancing drug availability with safety are analyzed alongside the integration of digital tools, collaborative initiatives, and real-world evidence. Recommendations emphasize leveraging technology, harmonizing regulatory frameworks, and fostering patient involvement to enhance the effectiveness of PMS and safeguard public health.